Storage and handling
Other information • read all warnings and directions before use. Keep carton. • store at 20-25°C (68-77°F) • avoid excessive heat above 40°C (104°F)
Other information • read all warnings and directions before use. Keep carton. • store at 20-25°C (68-77°F) • avoid excessive heat above 40°C (104°F)
Acetaminophen USP, 250 mg
Ibuprofen USP, 125 mg (NSAID*)
*nonsteroidal anti-inflammatory drug
Pain Reliever
Pain Reliever
Uses
Warnings
This product contains acetaminophen. Severe liver damage may occur if you take:
Acetaminophen allergy alert: may cause severe skin reactions. Symptoms may include:
If skin reaction occurs, stop use and seek medical help right away.
NSAID allergy alert: ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin.
Symptoms may include:
If an allergic reaction occurs, stop use and seek medical help right away.
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.
If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
adults and children 12 years and over |
|
children under 12 years |
|
Other information
Inactive ingredients
black iron oxide, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, glyceryl dibehenate, hypromellose, polydextrose, polyethylene glycol, pregelatinized starch, propylene glycol, sodium lauryl sulfate, titanium dioxide
Questions or comments?
call 1-888-375-3784 Weekdays (8 AM to 8 PM EST)
Acetaminophen 250 mg and
Ibuprofen 125 mg Tablets
Pain Reliever
Acetaminophen 250 mg and Ibuprofen 125 mg Tablets
Pain Reliever
| Class | Version | Type | Effective |
|---|---|---|---|
| IBUPROFEN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20191108 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 43598-052-05 | Acetaminophen 250 mg and Ibuprofen 125 mg | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | 6 | |
| 43598-052-14 | Acetaminophen 250 mg and Ibuprofen 125 mg | 144 in 1 BOTTLE | TABLET, FILM COATED | 144 | 6 | |
| 43598-052-18 | Acetaminophen 250 mg and Ibuprofen 125 mg | 18 in 1 BOTTLE | TABLET, FILM COATED | 18 | 6 | |
| 43598-052-18 | Acetaminophen 250 mg and Ibuprofen 125 mg | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 6 | |
| 43598-052-25 | Acetaminophen 250 mg and Ibuprofen 125 mg | 250 in 1 BOTTLE | TABLET, FILM COATED | 250 | 6 | |
| 43598-052-25 | Acetaminophen 250 mg and Ibuprofen 125 mg | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 6 | |
| 43598-052-95 | Acetaminophen 250 mg and Ibuprofen 125 mg | 250 in 1 BOTTLE | TABLET, FILM COATED | 250 | 6 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 43598-052 | 43598-052-18, 43598-052-25, 43598-052-05, 43598-052-14, 43598-052-95 |
Every source-derived ingredient row is available through these pages.
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A218247-001 | ACETAMINOPHEN AND IBUPROFEN | ACETAMINOPHEN; IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2024-08-23 |
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A218247-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2024-08-23 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A218247-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2024-08-23 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A218247-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2024-08-23 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218247-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2024-08-23 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A218247-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2024-08-23 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A218247-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2024-08-23 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A218247-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2024-08-23 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A218247-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2024-08-23 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A218247-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2024-08-23 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A218247-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2024-08-23 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A218247-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2024-08-23 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A218247-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2024-08-23 | d06236e962d9… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218247-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2024-08-23 | a50c72e98297… |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Acetaminophen 250 mg and Ibuprofen 125 mg | ACETAMINOPHEN AND IBUPROFEN | Dr. Reddy's Labortories Inc | 3e65c8a3-498e-1a2a-bb76-18e28ae2c73c | 2025-04-04 | Warnings | 43598-052-95 43598-052-18 43598-052-05 43598-052-14 43598-052-25 43598-052 43598005225 43598005205 43598005218 43598005295 43598005214 49a54544-f18b-6461-9ed0-2740e8df4b6c 3e65c8a3-498e-1a2a-bb76-18e28ae2c73c |
Adverse event summaries are temporarily unavailable. Other product information remains available.